Oral anaerobic glutathione supplement in liposome suspension

ABSTRACT

The disclosure relates to compositions, methods and systems for treating cellular oxidative stress in a user. A composition of the disclosure includes an effective amount of reduced glutathione for reducing oxidative stress in the user and a deoxygenated water solvent. The composition is encapsulated in a phospholipid liposome structure and packaged and stored in an airless dispenser configured to maintain an anaerobic environment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/955,608 filed Apr. 17, 2018 which claims the benefit under 35 U.S.C.§ 119(e) of U.S. Provisional Application No. 62/460,725 filed Feb. 17,2017, which are incorporated herein by reference in its entirety,including but not limited to those portions that specifically appearhereinafter, the incorporation by reference being made with thefollowing exception: In the event that any portion of theabove-referenced applications are inconsistent with this application,this application supercedes said portion of said above-referencedapplication.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable.

BACKGROUND

The disclosure relates to compositions, methods and systems forimproving free radical levels in a user and/or for the treatment ofoxidative stress in a user. The compositions, methods, and systems ofthe disclosure may also be applicable in the treatment or support of thebody's natural detoxification process and/or the treatment or support ofthe body's natural defense systems for combatting viruses, bacteria,heavy metal toxicity, radiation, certain medications, the process ofaging, and the like.

The present disclosure relates to a bio-effective nutraceuticalcomposition. Specifically, the disclosure relates to a compositioncomprising reduced glutathione (GSH) manufactured to be substantiallyanaerobic and remaining in a reduced glutathione state at composition.

What is needed are compositions, methods, and systems that are efficientfor reducing free radical levels in a user and alleviating oxidativestress in the user. As will be seen, the disclosure provides suchcompositions, methods, and systems that can treat oxidative stress andimproving the body's natural detoxification process and natural defensesystems in an effective and elegant manner.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive implementations of the disclosure aredescribed with reference to the following figures, wherein likereference numerals refer to like parts throughout the various viewsunless otherwise specified. Advantages of the disclosure will becomebetter understood with respect to the following description andaccompanying drawing where:

FIG. 1 illustrates the chemical structure of reduced glutathione (GSH)according to one implementation consistent with the teachings andprinciples of the disclosure;

FIG. 2 illustrates the chemical oxidation reaction of reducedglutathione (GSH) to oxidized glutathione (GSSG) according to oneimplementation consistent with the teachings and principles of thedisclosure;

FIG. 3 illustrates a standard curve for reduced glutathione resultingfrom a short-term analysis of a clinical example consistent with theteachings and principles of the disclosure;

FIG. 4 illustrates a standard curve for reduced glutathione resultingfrom a long-term analysis of a clinical example consistent with theteachings and principles of the disclosure;

FIG. 5 illustrates concentrations of reduced glutathione resulting froma short-term analysis of a clinical example consistent with theteachings and principles of the disclosure;

FIG. 6 illustrates concentrations of oxidized glutathione resulting froma short-term analysis of a clinical example consistent with theteachings and principles of the disclosure;

FIG. 7 illustrates ratios of reduced glutathione to oxidized glutathioneresulting from a short-term analysis of a clinical example consistentwith the teachings and principles of the disclosure;

FIG. 8 illustrates concentrations of reduced glutathione resulting froma long-term analysis of a clinical example consistent with the teachingsand principles of the disclosure;

FIG. 9 illustrates concentrations of oxidized glutathione resulting froma long-term analysis of a clinical example consistent with the teachingsand principles of the disclosure;

FIG. 10 illustrates ratios of reduced glutathione to oxidizedglutathione resulting from a long-term analysis of a clinical exampleconsistent with the teachings and principles of the disclosure;

FIG. 11 illustrates ratios of reduced glutathione to oxidizedglutathione resulting from a long-term analysis versus the baselineanalysis of a clinical example consistent with the teachings andprinciples of the disclosure;

FIG. 12 illustrates a schematic block diagram of a method for reducingoxidative stress in a user; and

FIG. 13 illustrates a schematic block diagram of a method for reducingoxidative stress in a user.

DETAILED DESCRIPTION

The disclosure extends to compositions, methods, and systems foralleviating oxidative stress in a user and/or the reducing the levels ofdamaging free radicals in the user that may be accumulated due toviruses, bacteria, heavy metal toxicity, radiation, certain medications,the process of aging, and the like. The disclosure further extends tothe anaerobic manufacture, packaging, and delivery of therapeuticamounts of bio-effective reduced glutathione (GSH).

The disclosure extends to a highly bio-active composition for reducingoxidative stress in a user. The composition includes reduced glutathioneand a deoxygenated water solvent, and the composition may beencapsulated in a phospholipid liposome structure to provide effectivedelivery to the user. The composition provides unexpectedly good resultsin maintaining reduced glutathione that is effective for alleviatingcellular oxidative stress in a user and/or reducing a level of freeradicals in the user's body. Compared with compositions known in the artthat purport to provide reduced glutathione, the composition of thepresent disclosure provides unexpectedly good results in preventing theoxidation of reduced glutathione (GSH) to oxidized glutathione (GSSG)that is commonly found in purported GSH supplements known in the art.The composition provides unexpectedly good results in passing reducedglutathione through the mucosa membrane of a user directly into theuser's bloodstream such that the user may receive effective relief fromcellular oxidative stress and may reduce the levels of free radicals inthe body. The composition of the disclosure provides unexpectedly goodresults in increasing levels of reduced glutathione in a user's bloodserum over short-term and long-term periods. The composition furtherprovides unexpectedly good results in improving the ratio of reducedglutathione to oxidized glutathione in a user's blood serum overshort-term and long-term periods.

The disclosure further extends to the anaerobic manufacture andpackaging of a composition for reducing oxidative stress in a user. Thecomposition provides reduced glutathione in a deoxygenated watersolvent, wherein all or nearly all oxygen gas (O₂) commonly found inwater has been removed. The composition is encapsulated in aphospholipid liposome structure that provides some protection againstoxidation of the reduced glutathione. The composition is furtherpackaged in an airless dispenser. The composition provides highbio-activity in alleviating cellular oxidative stress in a user andreducing levels of free radicals in a user's body.

In the following description of the disclosure, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific implementations in which the disclosuremay be practiced. It is understood that other implementations may beutilized, and structural changes may be made without departing from thescope of the disclosure.

In describing and claiming the subject matter of the disclosure, thefollowing terminology will be used in accordance with the definitionsset out below.

As used herein, the terms “comprising,” “including,” “containing,”“characterized by,” and grammatical equivalents thereof are inclusive oropen-ended terms that do not exclude additional, unrecited elements ormethod steps.

As used herein, the phrase “consisting of” and grammatical equivalentsthereof exclude any element, step, or ingredient not specified in theclaim.

As used herein, the phrase “consisting essentially of” and grammaticalequivalents thereof limit the scope of a claim to the specifiedingredients, materials or steps and those that do not materially affectthe basic and novel characteristic or characteristics of the claimeddisclosure.

As used herein, “effective amount” means an amount of an ingredient or acomponent of the product that is nontoxic, but sufficient to provide thedesired effect and performance at a reasonable benefit/risk ratioattending any dietary supplement or product. For example, an effectiveamount of a vitamin or mineral is an amount sufficient to prevent adeficiency thereof and to reduce the incidence of some adverse effects.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meanings as commonly understood by one of ordinary skillin the art to which this disclosure pertains and belongs.

Oxidative stress, or high levels of free radicals in the body, isresponsible for numerous health issues and is virtually impossible toavoid. Oxidative stress reflects an imbalance between the systemicmanifestation of reactive oxygen species and the body's ability toreadily detoxify the reactive intermediates or repair the resultingdamage. Disturbances in the body's normal redox state of cells can causetoxic effects through the production of peroxides and free radicals thatdamage all components of a cell, including proteins, lipids, and DNA.Oxidative stress from oxidative metabolism causes base damage as well asstrand breaks in DNA. Further, some reactive oxidative species act ascellular messengers in redox signaling. Thus, oxidative stress may causedisruptions in the body's normal mechanisms of cellular signaling. Inhumans, oxidative stress is thought to be involved in the development ofattention deficit hyperactivity disorder, cancer, Parkinson's disease,Lafora disease, Alzheimer's disease, atherosclerosis, heart failure,myocardial infarction, fragile X syndrome, sickle-cell disease, licenplanus, vitiligo, autism, infection, chronic fatigue syndrome, anddepression, among other.

Chemically, oxidative stress is associated with increased production ofoxidizing species or a significant decrease in the effectiveness ofantioxidant defenses, such as glutathione. Reduced glutathione (GSH) isoften referred to as the body's master antioxidant. Glutathione iscomposed of three amino acids, including cysteine, glycine, andglutamine, and glutathione can be found in virtually every cell of thebody. The highest concentration of glutathione is typically found in theliver where it serves a critical function in the body's naturaldetoxification process. This natural detoxification process is importantfor treating oxidative stress in the body and avoiding the production ofdamaging peroxides and free radicals.

Glutathione is an important component of the body's natural defensesystem. Glutathione can be depleted by compositions or processes thatare associated with free-radical damage, including for example, viruses,bacteria, heavy metal toxicity, radiation, certain medications, and theprocess of aging. The depletion of glutathione is associated with lowerimmune function, increased vulnerability to infection, and a reductionin the liver's ability to detoxify the body. As the generation of freeradicals exceeds the body's ability to neutralize and eliminate them,oxidative stress occurs. A primary function of glutathione is toalleviate oxidative stress.

Reduced glutathione is under tight homeostatic control bothintracellularly and extracellularly. A dynamic balance is maintainedbetween the synthesis of reduced glutathione, its recycling fromoxidized glutathione, and its utilization.

Reduced glutathione is utilized as a cofactor by multiple peroxidaseenzymes to detoxify peroxides that are generated by oxygen radicalattack on biological molecules. Reduced glutathione is further utilizedas a cofactor by transhydrogenases to reduce oxidized centers on DNA,proteins, and other biomolecules. Reduced glutathione is furtherutilized as a cofactor by glutathione S-transferases (hereinafter “GST”)to conjugate reduced glutathione with endogenous substances (e.g.estrogens), exogenous electrophiles (e.g. arene oxides, unsaturatedcarbonyls, and organic halides), and diverse xenobiotics. Low GSTactivity may increase risk for disease, and paradoxically, some reducedglutathione conjugates can also be toxic.

Reduced glutathione can be depleted by direct attack by free radicalsand other oxidative agents. The homeostatic glutathione redox cycleattempts to keep reduced glutathione repleted as it is being consumed.Amounts available from foods are limited (less than 150 mg/day), andoxidative depletion can outpace synthesis.

The liver is the largest reservoir of reduced glutathione. Theparenchymal cells synthesize reduced glutathione for P450 conjugationand numerous other metabolic requirements, then export reducedglutathione as a systemic source of SH-reducing power. Reducedglutathione is carried in the bile to the intestinal luminalcompartment. Epithelial tissues of the kidney tubules, intestinallining, and lungs have substantial P450 activity and a modest capacityto export reduced glutathione. However, it will be appreciated thatglutathione exists in the intracellular and extracellular spaces of allcells and is present throughout the body.

Equivalents of reduced glutathione circulate in the blood predominatelyas cystine (i.e., the oxidized and more stable form of cysteine.) Cellsimport cystine from the blood, reconvert it to cysteine, and form it tosynthesize reduced glutathione. Conversely, inside the cell, reducedglutathione assists in re-reducing oxidized forms of other antioxidantssuch as ascorbate and alpha-tocopherol.

Reduced glutathione is an important cell protectant; it directlyquenches reactive hydroxyl free radicals, other oxygen-centered freeradicals, and radical centers on DNA and other biomolecules. Reducedglutathione is a primary protectant of the skin, lens, cornea, andretina against radiation damage and other biochemical foundations ofP450 detoxification in the liver, kidneys, lungs, intestinal, epithelia,and other organs.

Reduced glutathione is the essential cofactor for many enzymes thatrequire thiol-reducing equivalents, and it helps keep redox-sensitiveactive sites on enzymes in the necessary reduced state. Higher-orderthiol cell systems, the metallothioneins, thioredoxins, and other redoxregulator proteins are ultimately regulated by the levels of reducedglutathione, and the ratio of reduced glutathione to oxidizedglutathione. The balance of reduced and oxidized glutathione is crucialto homeostasis in the body, to stabilizing the cellular biomolecularspectrum, and to facilitating cellular performance and survival. Reducedglutathione and its metabolites interface with energetics andneurotransmitter syntheses through several prominent metabolic pathways.Reduced glutathione availability down-regulates the pro-inflammatorypotential of leukotrienes and other eicosanoids. Recently discoveredS-nitroso metabolites, generated in vivo from reduced glutathione andnitric oxide (NO), further diversify the impact of reduced glutathioneon the body's metabolism.

According to the present disclosure, a reduced glutathione supplementmay be manufactured in an anaerobic environment using one or morenon-reactive gasses to ensure the maintenance of the reduced form,rather than the oxidized form, of glutathione. Additionally,de-oxygenated water may be used during the manufacturing process and asa carrier for the supplement. By using de-oxygenated water, very littleof the oxygen is available in the water to convert the reducedglutathione to oxidized glutathione.

In an embodiment of the disclosure, a composition for reducing oxidativestress in a user is disclosed. The composition includes an effectiveamount of reduced glutathione for reducing oxidative stress in the user,and a deoxygenated water solvent. In an embodiment, the composition isencapsulated in a phospholipid liposome structure. In an embodiment, thecomposition is packaged in an airless dispenser configured to maintainan anaerobic environment.

In a further embodiment of the disclosure, a method of reducingoxidative stress in a user is disclosed. The method includes providing acomposition to the user, wherein the composition comprises an effectiveamount of reduced glutathione for reducing oxidative stress in the userand a deoxygenated water solvent. In an embodiment, the composition isencapsulated in a phospholipid liposome structure and the composition ispackaged in an airless dispenser configured to maintain an anaerobicenvironment.

In a further embodiment of the disclosure, a method for manufacturing acomposition for reducing oxidative stress in a user is disclosed. Themethod includes mixing reduced glutathione powder and deoxygenated waterin an anaerobic environment to form a reduced glutathione solution. Themethod includes packaging the reduced glutathione solution in an airlessdispenser in an anaerobic environment such that the reduced glutathioneis not substantially exposed to an oxygen source from manufacture todispensing.

In an embodiment of the disclosure, reduced glutathione is dissolved ina deoxygenated water solvent. The deoxygenated water solvent has haddissolved oxygen (O₂) gasses removed from the water. Various techniquesfor removing dissolved oxygen from water are known in the art, includingfor example, boiling water at atmospheric pressure, boiling water atreduced pressure, purging water with nitrogen gas (N₂), argon gas (Ar),or other inert gas, and sonication of the water under reduced pressure.Additionally, water deoxygenation may be performed by bio reactiveprocesses including, for example, yeast-based bio reactive processes. Inan embodiment, highly pure deoxygenated water is utilized in combinationwith other components of the composition disclosed herein.

In an embodiment, the composition is encapsulated in a liposomestructure. The liposome structure may be a spherical lipid-based vesicleconstructed from sunflower-based lecithin rich in plant-basedphospholipids. The liposome structure may have a hollow core includingan aqueous solution of the reduced glutathione in deoxygenated waterwith other components as disclosed herein. The liposome structure mayprovide enhanced and targeted delivery to a user through the user'soral, esophageal, and gastrointestinal mucosa lining. It should beappreciated that the liposome structure may comprise any suitableliposome structure and is not limited to a spherical lipid-based vesiclefrom sunflower-based lecithin. Sunflower-based lecithin has a lowaffinity for allergenic response as compared to soy lecithin and may beadvantageous for certain users who are disposed to allergenic reactions.

The liposome structure of the disclosure comprises a natural positivecharge and has a high affinity for mucosal binding. In an embodiment,the liposome structure is configured to provide gradual delivery of thedeoxygenated aqueous reduced glutathione solution from the liposome corethrough the mucosal lining of a user into the user's bloodstream.

In an embodiment, the phospholipids in the lecithin are responsible fororganized formation of a liposome vesicle by providing lipid molecules,especially phosphatidylcholine, containing a hydrophilic head andhydrophobic tail, that has a binding capacity to form a sphericalvesicle including at least one lipid bilayer. The hydrophilic head islocated on an outer shell and the hydrophobic tail is oriented toward aninner surface of the vesicle shell. A liposome has an aqueous solutioncore surrounded by a hydrophobic membrane in the form of a lipidbilayer. Hydrophilic solutes, such as reduced glutathione, are dissolvedin the core and cannot readily pass through the lipid bilayer. Todeliver the molecules to a site of action, the lipid bilayer may fusewith other bilayers, such as a cell wall, and deliver the liposomecontents.

In an embodiment, the liposome structure is defined as a distribution ofSmall Unilayer Vesicles (SUV) and Large Unilayer Vesicles (LUV). SUVliposomes are defined as a single unilayer vesicle having a diameterbetween about 20 nm to about 100 nm. LUV liposomes are defined as asingle inlayer vesicle having a diameter between about 100 nm to about400 nm. In an embodiment, the majority of the liposomes in theformulation are of the SUV type. In an embodiment, the compositionincludes a higher loading of lecithin to provide more phospholipids tomaximize the number of liposomes in the composition. In an embodiment,the liposomes comprise more than 8 wt % the total composition. In anembodiment, the liposomes comprise more than l0 wt % the totalcomposition. An increased liposomal population may maximize theencapsulation of the deoxygenated aqueous reduced glutathione and soluteto a theoretical efficiency of about 50% of the aqueous medium.

In an embodiment, liposomes of the composition primarily perform thefunction of targeted delivery and slow release of the deoxygenatedaqueous reduced glutathione. Further, some oxidative protection isafforded by the liposome vesicle in the form of an oxygen permeabilityrate limited reducing oxidation of the internal contents afterdispensing the composition. During storage in the consumer liquidproduct package, which in an embodiment includes an airless dispenser,eventually all components of the composition will reach a similar oxygensaturation and level.

Referring now to the figures, FIG. 1 illustrates the chemical structure100 of reduced glutathione. As illustrated, reduced glutathionecomprises glutamic acid 102, cysteine 104, and glycine 106. Reducedglutathione (GSH) is a linear tripeptide of L-glutamine, L-cysteine, andglycine. Reduced glutathione is technically referred to asN-L-gamma-glutamyl-cysteinyl glycine or L-glutathione. The moleculeincludes a sulfhydryl (SH) group on the cysteinyl portion that accountsfor its strong electron-donating character that enables glutathione tobe effective in reducing oxidative stress in the body. Glutathione isoxidized as an electron is lost, and two such molecules (with a lostelectron) become linked or dimerized by a disulfide bridge. Thedimerized molecules form glutathione disulfide or oxidized glutathione(GSSG). The linkage is reversible upon re-reduction.

The synthesis of reduced glutathione includes two closely linked andenzymatically-controlled reactions that utilize adenosine triphosphate(ATP). First, cysteine and glutamate are combined by gamma-glutamylcysteinyl synthetase. Second, reduced glutathione synthetase combinesgamma-glutamylcysteine with glycine to generate reduced glutathione. Asthe levels of reduced glutathione rise, the processes are self-limitedagainst further production of reduced glutathione. Otherwise, cysteineavailability is usually rate-limiting. Fasting, protein-energymalnutrition, and other dietary amino acid deficiencies limit thesynthesis of reduced glutathione. The recycling of reduced glutathioneis catalyzed by glutathione disulfide reductase, which uses reducingequivalents from nicotinamide adenine dinucleotide phosphate (NADPH) toreconvert oxidized glutathione to glutathione disulfide. The reducingpower of ascorbate helps conserve systemic reduced glutathione.

FIG. 2 illustrates the oxidation reaction 204 of reduced glutathione(GSH) 202 to oxidized glutathione (GSSG) 208. The reaction 204 producestwo electrons and two protons as illustrated at 206.

In an embodiment of the disclosure, a composition is provided to a user.The composition includes 99.9% purity reduced glutathione powder. Thereduced glutathione powder is solubilized in a deoxygenated watersolvent and encapsulated in a plant-based phospholipid liposomestructure. The composition includes an effective amount of stevia,natural lemon essential oil, and natural peppermint essential forimproving the overall flavor of the composition for human oralconsumption. In an embodiment, the composition includes from about 525mg to about 575 mg of reduced glutathione per 4 g of solution.

In an embodiment, the resulting liquid composition is packaged in anairless dispenser that is configured to maintain the composition in ananaerobic environment. As such, the airless dispenser protects thereduced glutathione from degradation and conversion to oxidizedglutathione. Applicant recognizes that previous purported supplementsincluding reduced glutathione suffer from a sulfur smell due to thestrong oxidation of reduced glutathione. As such, the airless dispenserextends the effective shelf-life of the reduced glutathione in thepresent disclosure by substantially eliminating contact of the reducedglutathione with oxygen, even after first use of the composition.Applicant recognizes that other forms of packaging and delivery resultin the reduced glutathione making contact with oxygen and thus rapidlydegrading and oxidizing into oxidized glutathione, even if a successfulmanufacture of reduced glutathione is initially achieved.

Clinical Example

In one study conducted to test the effectiveness of a compositioncomprising reduced glutathione as disclosed above, the bio-effectivenessand availability of reduced glutathione in the body was greatly enhancedcompared with purported GSH supplements known in the art. Thecomposition provided unexpectedly good results given that purported GSHsupplements known in the art in fact fail to deliver reduced glutathioneto the user.

In one clinical study, a composition including reduced glutathione in adeoxygenated water solvent was provided to a user. The composition wasencapsulated in a phospholipid liposome structure and packaged anddelivered from an airless dispenser. The composition included 550±2 mgof reduced glutathione per 4 g of solution. The composition was providedto three human volunteers as a liquid-based oral supplement, and it wasprovided to one human volunteer as a liquid-based topical treatment tobe applied topically. The human serum levels of reduced glutathione andoxidized glutathione were sampled initially before ingestion toestablish a baseline level, and the serum levels were again sampledthree times over eight hours after ingestion or application of thecomposition. The participants continued to take the composition onceevery morning at least thirty minutes before meals for four weeks. Theserum levels of the participants were sampled once each week during thefour-week study period to collect data for long-term effects of thecomposition.

Each participant experienced a short-term increase in serum levels ofreduced glutathione equal to at least a 30% increase in the presence ofreduced glutathione in the serum. Each participant experienced along-term progressive reduction of oxidized glutathione equal to atleast a 30% reduction in the presence of oxidized glutathione in theserum. As discussed previously, the ratio of reduced glutathione tooxidized glutathione is an important and well-understood marker forcellular oxidative stress. The results of the clinical example indicatethat the composition was bioavailable unlike other pill and capsuledelivery forms of purported GSH supplements. Further, the compositionprovided long-term reduction in systemic cellular oxidative stress ineach of the participants.

In the above-referenced study, four persons agreed to participate. Theparticipants included one male and one female ranging in age from 23 to83 years of age. The participants were assigned a number from #1 to #4as follows: (1) 61-year-old female, (2) 55-year-old male, (3)23-year-old female, and (4) 83-year-old female. Each of the participantswas permitted to each the morning of the first serum collection butrefrained from taking antioxidant dietary supplements during the courseof the four-week study period. The participants' blood was collected forbaseline measurements at approximately 8:00 AM by intravenous puncture.The serum was extracted, processed, and frozen for later analysis. Afterthe collection of the baseline serum sample, the participantsimmediately consumed the composition by dispensing 4 mL of the liquidcomposition into their mouth and swishing for 15-20 seconds beforeswallowing. The participants refrained from drinking for 15 minutesafterward. The participant who used the product topically appliedapproximately the same amount of the composition onto the abdomen andsoft areas under the arms. Samples of the participants' blood wereagainst collected at 2 hours, 6 hours, and 8 hours after the firstcollection. The participants consumed the composition one time per dayin the morning for a four-week period. The participants' blood wascollected each week at exactly seven-day intervals for four weeks atapproximately 10:00 AM. The participants were instructed to consume thecomposition four hours prior to collection. The serum was extracted,processed, and frozen for later analysis. All serum samples were assayedwithin thirty days of collection.

Analysis of the Serum Samples.

The serum samples were analyzed to determine the levels of reducedglutathione and oxidized glutathione. The serum samples were analyzedusing the BioVision (Milpitas, Calif.) Glutathione Fluorometric AssayKit (GSH, GSSG, and Total) k264. Wasatch Scientific Laboratories inMurray, Utah, USA was contracted to perform the assay using theBioVision fluorometric kit and method. Whole blood samples werecollected and immediately centrifuged to separate the serum from the redblood cells and heavier components. Approximately 120 μL of serum wasadded to 40 μL of an ice-cold perchloric acid PCA buffer in a 1 mLaliquot. The solution was vortexed and stored on ice for five minutes.The solution was centrifuged at 13,000 G for two minutes, and thesupernatant was collected and frozen at −60 degC.

FIG. 3 illustrates a standard curve for reduced glutathione for theshort-term analysis. The standard curve for reduced glutathione andoxidized glutathione were created, and then the prepared serum sampleswere tested at two dilutions to determine the optimal dilution for thebest dynamic resolution of the assay. The samples were processed andassayed in duplicate pairs at the chosen dilution. The results of eachpair were reviewed and compared for repeatability and best-fit sampleswere used. FIG. 3 illustrates a mass of reduced glutathione (GSH) innanograms on the x-axis plotted against the relative fluorescence units(RFU) on the y-axis.

FIG. 4 illustrates a standard curve for reduced glutathione for thelong-term analysis. The standard curve for reduced glutathione andoxidized glutathione were created, and then the prepared serum sampleswere tested at two dilutions to determine the optimal dilution for thebest dynamic resolution of the assay. The samples were processed andassayed in duplicate pairs at the chosen dilution. The results of eachpair were reviewed and compared for repeatability and best-fit sampleswere used. FIG. 3 illustrates a mass of reduced glutathione (GSH) innanograms on the x-axis plotted against the relative fluorescence units(RFU) on the y-axis. The results of the assay were compiled anddisplayed in tabular and graphical form. In addition, ratiometricresults of reduced glutathione (GSH) and oxidized glutathione (GSSG)were created for each sample.

FIG. 5 illustrates concentrations of reduced glutathione for each of thefour aforementioned participants for the short-term analysis. FIG. 5illustrates concentrations in μg/mL for each of four possible serumdraws for each of the four participants. Draw one is the baseline draw.Draw two was taken at the baseline plus four hours. Draw three was takenat the baseline plus six hours. Draw four was taken at the baseline pluseight hours. As illustrated in FIG. 5, all participants in theshort-term analysis experienced an increase in serum levels of reducedglutathione. The increase concentration of reduced glutathione appearedto peak at approximately six to eight hours after ingestion. Theincrease in reduced glutathione was on average 30% above baselinelevels. Participant one, a female, applied the composition topically andexperienced elevated serum levels of reduced glutathione.

FIG. 6 illustrates concentrations of oxidized glutathione for each ofthe four aforementioned participants for the short-term analysis. FIG. 6illustrates concentrations in μg/mL for each of four possible serumdraws for each of the four participants. Draw one is the baseline draw.Draw two was taken at the baseline plus four hours. Draw three was takenat the baseline plus six hours. Draw four was taken at the baseline pluseight hours. Participant one, a female, applied the compositiontopically and experienced elevated serum levels of reduced glutathione.As illustrated in FIG. 6, concentrations of oxidized glutathioneappeared to respond differently for each participant. The mostsignificant change in levels of oxidized glutathione was an almost 50%reduction in participant one who applied the composition topically. Inparticipants three and four, the levels of oxidized glutathione onaverage reduced slightly from baseline.

FIG. 7 illustrates the ratios of reduced glutathione to oxidizedglutathione for each of the participants for the short-term analysis. Asillustrated in FIG. 7, the composition provided a short-term antioxidantbenefit to each of the participants. The reduced/oxidized glutathioneratio is an accepted standard to measure cellular oxidative stress. Thisstudy illustrates the redox ratio trend over time. After ingestion, eachparticipant experienced an increase in the redox ratio compared to thebaseline, even eight hours after consuming or applying the composition.This study demonstrates bio-utilization of the redox ratio.

FIG. 8 illustrates concentrations of reduced glutathione for each of thefour aforementioned participants for the long-term analysis. FIG. 8illustrates concentrations in μg/mL for each of three weekly serum drawsfor each of the four participants. Draw one (not shown due to laboratoryerror) was taken at 10:00 AM exactly one week after ingestion orapplication of the composition. Draw two occurred at 10:00 AM two weeksafter ingestion or application of the composition. Draw three occurredat 10:00 AM exactly three weeks after ingestion or application of thecomposition. Draw four occurred at 10:00 AM exactly four weeks afteringestion or application of the composition. The human serum sampleswere assayed for concentrations of reduced and oxidized glutathione.Participant one, a female, applied the composition topically andparticipants two, three, and four ingested orally a liquid-basedcomposition.

As illustrated in FIG. 8, the participants' serum levels of reducedglutathione show mixed results. Participants one and three demonstrateslevels of reduced glutathione that are very close to the baseline levelswithout significant increase. Participants two and four demonstratedlong-term increase in levels of reduced glutathione equal toapproximately 20-22%. The long-term serum levels of reduced glutathionewhen viewed alone showed positive results in participants two and four.

FIG. 9 illustrates concentrations of oxidized glutathione for each ofthe four aforementioned participants for the long-term analysis. FIG. 9illustrates concentrations in μg/mL for each of three weekly serum drawsfor each of the four participants. Draw one (not shown due to laboratoryerror) was taken at 10:00 AM exactly one week after ingestion orapplication of the composition. Draw two occurred at 10:00 AM two weeksafter ingestion or application of the composition. Draw three occurredat 10:00 AM exactly three weeks after ingestion or application of thecomposition. Draw four occurred at 10:00 AM exactly four weeks afteringestion or application of the composition. The human serum sampleswere assayed for concentrations of reduced and oxidized glutathione.Participant one, a female, applied the composition topically andparticipants two, three, and four ingested orally a liquid-basedcomposition.

As illustrated in FIG. 9, each of the four participants experienced asignificant decrease in long-term concentrations of oxidized glutathione(GSSG). As discussed previously, reduced glutathione is oxidized insidecells and converted to oxidized glutathione according to the reaction200 illustrated in FIG. 2. A portion of the oxidized glutathione isshuttled out of the cells and into the intracellular space and into theblood. When the ratio of reduced/oxidized glutathione is calculated, atrue reduction is cellular oxidation is evidence.

FIG. 10 illustrates the ratios of reduced glutathione to oxidizedglutathione for each of the four aforementioned participants for thelong-term analysis. As illustrated in FIG. 10, each of the participantsexperienced a sustained and cumulative decrease in oxidative stress. Thereduced/oxidized glutathione redox ratio increased for all participantsover the four weeks of ingesting or applying the composition. Applicantnotes that participant three and participant four represent a wide ageand health gap, where one is a 23-year-old healthy female and the otheris an 83-year old female with health issues due to age. The compositionhad a positive long-term effect in both the young participant and theolder participant, where the older participant experienced a greaterrise in the redox ratio. The data further shows that participant oneexperienced a redox benefit, even by applying the product topically.Applicant notes that participant one only applied about one-third of thedose compared to the oral participants, not following specific dosinginstructions. The results for all participants clearly demonstrates thebenefits of the novel composition comprising reduced glutathione that isdisclosed herein.

FIG. 11 illustrates the ratios of reduced glutathione to oxidizedglutathione for each of the participants for the long-term analysisversus the baseline analysis. FIG. 11 illustrates a comparison of thechange in redox over time as a result of supplementation with thecomposition disclosed herein. As illustrated in FIG. 11, allparticipants experienced a net average increase above baseline redoxratios, with participant two (55-year-old male) and participant four(83-year-old female) experiencing the greatest increase. Applicant notesthat it is anticipated that participant one (61-year-old female) wouldhave experienced a greater result if the dosage requirements for topicalapplication were followed more consistently.

The effects of the novel composition comprising reduced glutathione thatis disclosed herein indicate a bioavailability of reduced glutathioneand its short-term and long-term benefits in the human body as indicatedin the serum concentrations of reduced glutathione (GSH) and oxidizedglutathione (GSSG). All participants experienced a noticeable increasein GSH/GSSG redox ratio indicating a true reduction in cellularoxidative stress, with the older participants (age 55-83) experiencinghigher ratios. This is consistent with the assumption that olderparticipants have a greater amount of cellular oxidative stress to bereduced.

The results of the clinical example demonstrate conclusively that thecomposition disclosed herein is effectively delivering reducedglutathione. The composition includes reduced glutathione and adeoxygenated water solvent. The composition is manufactured and packagedin an anaerobic environment, in stark contrast with previous supplementsknown in the art that purport to deliver reduced glutathione but insteaddeliver oxidized glutathione. The careful maintenance of an anaerobiccondition, as disclosed herein, provides the unexpected result (givenall prior failures) of a composition that genuinely comprises reducedglutathione. The composition disclosed herein provides increased levelsof reduced glutathione, reduced cellular oxidative stress, and providesall the appurtenant benefits.

It should be appreciated that in various embodiments, dosage amounts maybe adjusted depending on the effect on any given individual, as well asthe biometrics of that individual. For example, a larger person mayrequire a higher dosage than a smaller person. Similarly, a personsuffering from an acute condition may benefit from a higher dose for atime until the condition is controlled, at which point a lower dose mayprovide sufficient management over time.

Referring now to FIG. 12, a schematic block diagram of a method 1200 forreducing oxidative stress in a user is illustrated. The method 1200begins and a composition is provided to a user at 1202. The compositioncomprises an effective amount of reduced glutathione for reducingoxidative stress in the user and a deoxygenated water solvent.

FIG. 13 illustrates a schematic block diagram of a method 1300 forreducing oxidative stress in a user. The method 1300 beings and acomposition is provided to a user at 1302. The composition includes aneffective amount of reduced glutathione for reducing oxidative stress inthe user, a deoxygenated water solvent, an effect amount of one or morepreservatives, and an effective amount of one or more natural flavoringcomponents for improving an overall flavor of the composition. Thecomposition is such that the reduced glutathione comprises from about 8%to about 14% by weight of the total composition. The composition is suchthat the reduced glutathione comprises a purity from about 98% to about99.9% purity. The composition is encapsulated in a phospholipid liposomestructure. The composition is packaged in an airless dispenserconfigured to maintain an anaerobic environment.

In one embodiment, the composition may be provided for the treatment ofcellular oxidative stress. When the composition is provided for thetreatment of cellular oxidative stress, it may be ingested orally oradministered topically. Applicant notes that in further embodiments thecomposition may be administered intravenously or intramuscularly, or ina tablet or powder form without departing from the scope of thedisclosure.

In one embodiment, the composition is provided for the treatment ofacute levels of free radicals in the body. In such an embodiment, thecomposition may be prepared for immediate intravenous or intramuscularadministration. The composition may further or alternatively be providedfor oral ingestion or topical application. In such an embodiment, thecomposition may be provided for regular administration after acutelevels of free radicals in the body have been treated and reduced tosafe levels.

In one embodiment, the composition is provided for the treatment ofacetaminophen overdose. The molecule known as N-acetylcysteine(hereinafter “NAC”) is known in the art for the treatment ofacetaminophen overdose. Pharmaceutical NAC is primarily used in medicalsettings for respiratory conditions, to manage acetaminophen overdose,and to prevent radio-contrast-induced nephropathy. However, thehalf-life of NAC is approximately 5.6 hours, and 30% of NAC is renallyexcreted by the body. Orally administered or inhaled NAC is associatedwith drowsiness, stomatitis, clamminess, rhinorrhea, and hemoptysis, andNAC is a category B pregnancy risk. In contrast with NAC, where thehalf-life is extremely short and the molecule is unstable, theshelf-life of the composition disclosed herein is at least one year.Therefore, the composition disclosed herein provides an alternative toNAC that is shelf-stable for an extended period and demonstrates highviability and efficacy.

In one embodiment, a 99.9% purity reduced glutathione powder issolubilized in deoxygenated water and encapsulated in a plant-basedphospholipid liposome structure. In the embodiment, the compositionincludes from about 8% to about 14% by weight reduced glutathione. Thecomposition includes from about 4% to about 11% by weight sunflowerlecithin. The composition includes from about 0.2% to about 0.6% byweight lemon essential oil. The composition includes from about 0.1% toabout 0.5% peppermint essential oil. The composition includes from about0.01% to about 0.25% stevia extract. The composition includes sodiumbenzoate and potassium sorbate.

In an embodiment of the disclosure, the composition includes highly pureL-glutathione reduced. In an embodiment of the disclosure, the reducedglutathione comprises a purity from about 98% to about 99.9% purity. Inan embodiment, the purity is from about 90% to about 99.9% purity. In anembodiment, the purity is from about 95% to about 99.9% purity. In anembodiment, the purity is from about 99.0% to about 99.9% purity. Itshould be appreciated that various ranges of purity may be extractedfrom any of the aforementioned ranges as if those ranges were disclosedexplicitly.

In an embodiment of the disclosure, the composition includes sunflowerlecithin. Lecithin is a fat found in a plurality of food products.Sunflower lecithin is a phospholipid comprising phosphatidylcholine,phosphatidylinositol, phosphatidylethanolamine, and omega-6 linoleicacid. Sunflower lecithin is associated with processing fats andsupporting cell membranes. In an embodiment of the disclosure, thesunflower lecithin is provided for encapsulating the composition andprotecting the reduced glutathione component.

In an embodiment of the disclosure, the composition includes lemonessential oil. Lemon essential oil may be provided to improve an overallflavor of the composition. As disclosed, oxidized glutathione provides asulfur smell that may be pungent or off-putting to a user. Additionally,the composition of the present disclosure may oxidize with oxygen in theair when the composition is being ingested, and the oxidized may causethe composition to become unpalatable to the user immediately before theuser ingests the composition. The lemon essential oil may be provided tocounteract the sulfur smell of the oxidized glutathione and increase theflavor of the composition.

In an embodiment of the disclosure, the composition includes peppermintessential oil. As discussed previously with respect to the lemonessential oil, the peppermint essential oil may be provided to improvethe overall flavor of the composition and mask a sulfur smell arisingfrom the oxidation of the reduced glutathione.

In an embodiment of the disclosure, the composition includes steviaextract. As discussed previously with respect to the lemon essential oiland/or the peppermint essential oil, the stevia extract may be providedto improve the overall flavor of the composition and mask a sulfur smellarising from the oxidation of the reduced glutathione.

In an embodiment of the disclosure, the composition includes sodiumbenzoate. Sodium has a chemical formula of NaC₇H₅O₂. Sodium benzoate isknown as a food preservative and has an E number of E211. Sodiumbenzoate is the sodium salt of benzoic acid and exists in the form whendissolved in water. As a food additive, sodium benzoate isbacteriostatic and fungistatic under acidic condition. Sodium benzoateis included in the composition as a preservative in an embodiment of thedisclosure.

In an embodiment of the disclosure, the composition includes potassiumsorbate. Potassium sorbate has a chemical formula ofCH₃CH═CH—CH=CH—CO₂K. Potassium sorbate is a known food preservative andhas an E number of E202. Potassium sorbate is known for inhibiting moldsand yeasts in a variety of foods and liquids. Potassium sorbate isincluded in the composition as a preservative in an embodiment of thedisclosure.

Examples

Chart 1 below shows an example embodiment of the composition. Componentswere dissolved in deoxygenated water and encapsulated in a plant-basedphospholipid liposome structure. The composition was packaged and storedin an airless dispenser.

CHART 1 Component Weight Percent Total Composition L-glutathione reduced14.00 Sunflower lecithin 10.50 Lemon essential oil 0.40 Peppermintessential oil 0.25 Sodium benzoate 0.10 Potassium sorbate 0.10 Steviaextract 0.10

Chart 2 below shows an example embodiment of the composition. Componentswere dissolved in deoxygenated water and encapsulated in a plant-basedphospholipid liposome structure. The composition was packaged and storedin an airless dispenser.

CHART 2 Component Weight Percent Total Composition L-glutathione reduced10.00 Sunflower lecithin 10.50 Lemon essential oil 0.40 Peppermintessential oil 0.25 Sodium benzoate 0.10 Potassium sorbate 0.10 Steviaextract 0.10

Chart 3 below shows an example embodiment of the composition. Componentswere dissolved in deoxygenated water and encapsulated in a plant-basedphospholipid liposome structure. The composition was packaged and storedin an airless dispenser.

CHART 3 Component Weight Percent Total Composition L-glutathione reduced8.00 Sunflower lecithin 10.50 Lemon essential oil 0.40 Peppermintessential oil 0.25 Sodium benzoate 0.10 Potassium sorbate 0.10 Steviaextract 0.10

Chart 4 below shows an example embodiment of the composition. Componentswere dissolved in deoxygenated water and encapsulated in a plant-basedphospholipid liposome structure. The composition was packaged and storedin an airless dispenser.

CHART 4 Component Weight Percent Total Composition L-glutathione reduced14.00 Sunflower lecithin 4.00 Lemon essential oil 0.40 Peppermintessential oil 0.25 Sodium benzoate 0.10 Potassium sorbate 0.10 Steviaextract 0.10

Chart 5 below shows an example embodiment of the composition. Componentswere dissolved in deoxygenated water and encapsulated in a plant-basedphospholipid liposome structure. The composition was packaged and storedin an airless dispenser.

CHART 5 Component Weight Percent Total Composition L-glutathione reduced14.00 Sunflower lecithin 11.00 Lemon essential oil 0.40 Peppermintessential oil 0.25 Sodium benzoate 0.10 Potassium sorbate 0.10 Steviaextract 0.10

Chart 6 below shows an example embodiment of the composition. Componentswere dissolved in deoxygenated water and encapsulated in a plant-basedphospholipid liposome structure. The composition was packaged and storedin an airless dispenser.

CHART 6 Component Weight Percent Total Composition L-glutathione reduced14.00 Sunflower lecithin 10.50 Lemon essential oil 0.20 Peppermintessential oil 0.25 Sodium benzoate 0.10 Potassium sorbate 0.10 Steviaextract 0.10

Chart 7 below shows an example embodiment of the composition. Componentswere dissolved in deoxygenated water and encapsulated in a plant-basedphospholipid liposome structure. The composition was packaged and storedin an airless dispenser.

CHART 7 Component Weight Percent Total Composition L-glutathione reduced14.00 Sunflower lecithin 10.50 Lemon essential oil 0.60 Peppermintessential oil 0.25 Sodium benzoate 0.10 Potassium sorbate 0.10 Steviaextract 0.10

Chart 8 below shows an example embodiment of the composition. Componentswere dissolved in deoxygenated water and encapsulated in a plant-basedphospholipid liposome structure. The composition was packaged and storedin an airless dispenser.

CHART 8 Component Weight Percent Total Composition L-glutathione reduced14.00 Sunflower lecithin 10.50 Lemon essential oil 0.40 Peppermintessential oil 0.10 Sodium benzoate 0.10 Potassium sorbate 0.10 Steviaextract 0.10

Chart 9 below shows an example embodiment of the composition. Componentswere dissolved in deoxygenated water and encapsulated in a plant-basedphospholipid liposome structure. The composition was packaged and storedin an airless dispenser.

CHART 9 Component Weight Percent Total Composition L-glutathione reduced14.00 Sunflower lecithin 10.50 Lemon essential oil 0.40 Peppermintessential oil 0.50 Sodium benzoate 0.10 Potassium sorbate 0.10 Steviaextract 0.10

Example 1 is a composition for reducing oxidative stress in a user. Thecomposition includes an effective amount of reduced glutathione forreducing oxidative stress in the user, and deoxygenated water solvent.

Example 2 is a composition as in Example 1, wherein the composition isencapsulated in a phospholipid liposome structure.

Example 3 is a composition as in any of Examples 1-2, wherein thecomposition is packaged in an airless dispenser configured to maintainan anaerobic environment.

Example 4 is a composition as in any of Examples 1-3, wherein thereduced glutathione comprises from about 8% to about 14% by weight ofthe total composition.

Example 5 is a composition as in any of Examples 1-4, wherein thecomposition comprises from about 500 mg to about 600 mg reducedglutathione per 4 g of the composition.

Example 6 is a composition as in any of Examples 1-5, wherein thereduced glutathione comprises a purity from about 98% to about 99.9%purity.

Example 7 is a composition as in any of Examples 1-6, further comprisingan effective amount of sodium benzoate for preserving the composition.

Example 8 is a composition as in any of Examples 1-7, further comprisingan effective amount of potassium sorbate for preserving the composition.

Example 9 is a composition as in any of Examples 1-8, further comprisingan effective amount of one or more natural flavoring components selectedfrom a list comprising: lemon essential oil, peppermint essential oil,monk fruit extract, agave, honey, natural cane sugar, glucose, fruitconcentrate, natural fruit powder, spearmint essential oil, wintergreenessential oil, orange essential oil, tangerine essential oil, lavenderessential oil, and stevia extract.

Example 10 is a composition as in any of Examples 1-9, wherein thecomposition is prepared for liquid oral consumption.

Example 11 is a composition as in any of Examples 1-10, wherein thecomposition is prepared for topical application.

Example 12 is a composition as in any of Examples 1-11, wherein thecomposition is prepared for intravenous or intramuscular administration.

Example 13 is a composition as in any of Examples 1-12, wherein thereduced glutathione comprises from about 4 g to about 20 g per 100 mL ofthe deoxygenated water solvent.

Example 14 is a method of reducing oxidative stress in a user. Themethod includes providing a composition to the user, wherein thecomposition includes an effective amount of reduced glutathione forreducing oxidative stress in the user, and a deoxygenated water solvent.

Example 15 is a method as in Example 14, wherein the composition isencapsulated in a phospholipid liposome structure.

Example 16 is a method as in any of Example 14-15, wherein thecomposition is packaged in an airless dispenser configured to maintainan anaerobic environment.

Example 17 is a method as in any of Example 14-16, wherein the reducedglutathione comprises from about 8% to about 14% by weight of the totalcomposition.

Example 18 is a method as in any of Example 14-17, wherein thecomposition comprises from about 500 mg to about 600 mg reducedglutathione per 4 g of the composition.

Example 19 is a method as in any of Example 14-18, wherein the reducedglutathione comprises a purity from about 98% to about 99.9% purity.

Example 20 is a method as in any of Example 14-19, wherein the reducedglutathione comprises a purity from about 99.0% to about 99.9% purity.

Example 21 is a method as in any of Example 14-20, wherein thecomposition further comprises an effective amount of sodium benzoate forpreserving the composition.

Example 22 is a method as in any of Example 14-21, wherein thecomposition further comprises an effective amount of potassium sorbatefor preserving the composition.

Example 23 is a method as in any of Example 14-22, wherein thecomposition further comprises an effective amount of one or more naturalflavoring components selected from a list comprising: lemon essentialoil, peppermint essential oil, monk fruit extract, agave, honey, naturalcane sugar, glucose, fruit concentrate, natural fruit powder, spearmintessential oil, wintergreen essential oil, orange essential oil,tangerine essential oil, lavender essential oil, and stevia extract.

Example 24 is a method as in any of Example 14-23, wherein thecomposition is provided to the user for liquid oral consumption.

Example 25 is a method as in any of Example 14-24, wherein thecomposition is provided to the user for topical administration.

Example 26 is a method as in any of Example 14-25, wherein thecomposition is provided to the user for intravenous or intramuscularadministration.

Example 27 is a method as in any of Example 14-26, wherein the reducedglutathione comprises from about 4 g to about 20 g per 100 mL of thedeoxygenated water solvent.

Example 28 is a method as in any of Example 14-27, wherein thecomposition is provided to the user for short-term treatment of cellularoxidative stress.

Example 29 is a method as in any of Example 14-28, wherein thecomposition increases blood-serum levels of reduced glutathione in theuser by at least 25%.

Example 30 is a method as in any of Example 14-29, wherein thecomposition is provided for long-term treatment of cellular oxidativestress.

According to one or more embodiments of the disclosure, a compositionmay include a combination of all or some, but not all, of the followingingredients:

(a) L-glutathione reduced;

(b) deoxygenated water;

(c) sunflower lecithin;

(d) lemon essential oil;

% (e) peppermint essential oil;

(f) sodium benzoate;

(g) potassium sorbate; and/or

(h) stevia extract.

Other embodiments of the composition may comprise, for example,concentrations of L-glutathione reduced as follows:

(a1) from 5% to 20% by weight the total composition;

(a2) from 6% to 19% by weight the total composition;

(a3) from 7% to 18% by weight the total composition;

(a4) from 8% to 17% by weight the total composition;

(a5) from 8% to 16% by weight the total composition;

(a6) from 8% to 15% by weight the total composition;

(a7) from 8% to 14% by weight the total composition;

(a8) from 8% to 13% by weight the total composition;

(a9) from 9% to 14% by weight the total composition;

(a10) from 10% to 14% by weight the total composition;

(a11) from 9% to 13% by weight the total composition;

(a12) from 10% to 12% by weight the total composition;

(a13) from 10% to 11% by weight the total composition.

With respect to ingredient (c) noted above for example, the amount ofsunflower lecithin that may be included in the final composition isbased on a percent by weight of the total weight of the finalcomposition described herein. The composition may comprise ingredient(c) for example, in concentrations as follows:

(c1) from 1% to 20% by weight the total composition;

(c2) from 2% to 19% by weight the total composition;

(c3) from 3% to 18% by weight the total composition;

(c4) from 4% to 17% by weight the total composition;

(c5) from 4% to 16% by weight the total composition;

(c6) from 4% to 15% by weight the total composition;

(c7) from 4% to 14% by weight the total composition;

(c8) from 4% to 13% by weight the total composition;

(c9) from 4% to 12% by weight the total composition;

(c10) from 4% to 11% by weight the total composition;

(c11) from 5% to 10% by weight the total composition;

(c12) from 6% to 9% by weight the total composition;

(c13) from 6% to 8% by weight the total composition.

With respect to ingredient (a) noted above for example, theL-glutathione reduced may comprise a purity before it is included in thecomposition in percentages as follows:

(aa1) from 97% to 99.9% purity;

(aa2) from 97.5% to 99.9% purity;

(aa3) from 98% to 99.9% purity;

(aa4) from 98.5% to 99.9% purity;

(aa5) from 99% to 99.9% purity;

(aa6) from 99.1% to 99.9% purity;

(aa7) from 99.2% to 99.9% purity;

(aa8) from 99.3% to 99.9% purity;

(aa9) from 99.4% to 99.9% purity;

(aa10) from 99.5% to 99.9% purity;

(aa11) from 99.6% to 99.9% purity;

(aa12) from 99.7% to 99.9% purity;

(aa13) from 99.8% to 99.9% purity.

The foregoing percentages, concentrations, and ratios are presented byexample only and are not intended to be exhaustive or to limit thedisclosure to the precise percentages, concentrations, and ratiosdisclosed. It should be appreciated that each value that falls within adisclosed range is disclosed as if it were individually disclosed as setforth herein. For example, a range indicating a weight percent fromabout 8% to about 14% additionally includes ranges beginning or endingwith all values within that range, including for example a rangebeginning at 8.1%, 8.2%, 8.3%, and so forth.

Also, according to one or more non-limiting embodiments of thedisclosure, any of the concentrations for ingredients (a) or (c), forexample, as listed above, may indicate the concentration for any ofingredients (b) and (d) thru (h), as listed above. For example, anembodiment of the disclosure may comprise, for example, (a7) from 8% to14% by weigh the total composition of L-glutathione reduced, and equalparts by weight of lemon essential oil and peppermint essential oil. Forexample, the composition may comprise all, or any combination of but notall, of the ingredients (a) thru (h).

The foregoing description has been presented for the purposes ofillustration and description. It is not intended to be exhaustive or tolimit the disclosure to the precise form disclosed. Many modificationsand variations are possible in light of the above teaching. Further, itshould be noted that any or all the aforementioned alternateimplementations might be used in any combination desired to formadditional hybrid implementations of the disclosure.

Further, although specific implementations of the disclosure have beendescribed and illustrated, the disclosure is not to be limited to thespecific forms or arrangements of parts so described and illustrated.The scope of the disclosure is to be defined by the claims appendedhereto, any future claims submitted here and in different applications,and their equivalents.

1. A composition comprising: reduced glutathione present in thecomposition from 5% to 20% by weight of the total composition; and adeoxygenated water solvent.
 2. The composition of claim 1, wherein thecomposition is encapsulated.
 3. The composition of claim 2, wherein thecomposition is packaged in an airless dispenser configured to maintainan anaerobic environment.
 4. The composition of claim 2, wherein thereduced glutathione comprises from about 8% to about 14% by weight ofthe total composition.
 5. The composition of claim 2, where thecomposition comprises from about 500 mg to about 600 mg reducedglutathione per 4 g of the composition.
 6. The composition of claim 1,wherein the reduced glutathione comprises a purity from about 98% toabout 99.9% purity.
 7. The composition of claim 1, further comprising aneffective amount of one or more preservatives selected from a listcomprising: potassium sorbate, sodium benzoate, sorbic acid, benzoicacid, natural benzyl alcohol, erythorbic acid, sodium erythorbate,ferrous gluconate, methyl paraben, potassium benzoate, rosemary extract,and sodium citrate.
 8. The composition of claim 1, further comprising aneffective amount of one or more natural flavoring components forimproving an overall flavor of the composition selected from a listcomprising: lemon essential oil, peppermint essential oil, monk fruitextract, agave, honey, natural cane sugar, glucose, fruit concentrate,natural fruit powder, spearmint essential oil, wintergreen essentialoil, orange essential oil, tangerine essential oil, lavender essentialoil, and stevia extract.
 9. The composition of claim 1, wherein thecomposition is prepared for liquid oral consumption.
 10. The compositionof claim 1, wherein the composition is prepared for topical application.11. The composition of claim 1, wherein the composition is prepared forintravenous or intramuscular administration.
 12. The composition ofclaim 1, wherein the composition comprises from about 4 g to about 20 greduced glutathione per 100 mL of the deoxygenated water solvent.
 13. Amethod comprising: providing a composition to the user, wherein thecomposition comprises: of reduced glutathione present in the compositionfrom 5% to 20% by weight of the total composition; and a deoxygenatedwater solvent.
 14. The method of claim 13, wherein the composition isencapsulated.
 15. The method of claim 14, wherein the composition ispackaged in an airless dispenser configured to maintain an anaerobicenvironment.
 16. The method of claim 14, wherein the reduced glutathionecomprises from about 8% to about 14% by weight of the total composition.17. The method of claim 14, wherein the composition comprises from about500 mg to about 600 mg reduced glutathione per 4 g of the composition.18. The method of claim 13, wherein the reduced glutathione comprises apurity from about 98% to about 99.9% purity.
 19. The method of claim 13,wherein the reduced glutathione comprises a purity from about 99.0% toabout 99.9% purity.
 20. The method of claim 13, wherein the compositionfurther comprises an effective amount of one or more preservativesselected from a list comprising: potassium sorbate, sodium benzoate,sorbic acid, benzoic acid, natural benzyl alcohol, erythorbic acid,sodium erythorbate, ferrous gluconate, methyl paraben, potassiumbenzoate, rosemary extract, and sodium citrate.
 21. The method of claim13, wherein the composition further comprises an effective amount of oneor more natural flavoring components for improving an overall flavor ofthe composition selected from a list comprising: lemon essential oil,peppermint essential oil, monk fruit extract, agave, honey, natural canesugar, glucose, fruit concentrate, natural fruit powder, spearmintessential oil, wintergreen essential oil, orange essential oil,tangerine essential oil, lavender essential oil, and stevia extract. 22.The method of claim 13, wherein the composition is provided to the userfor liquid oral consumption.
 23. The method of claim 13, wherein thecomposition is provided to the user for topical administration.
 24. Themethod of claim 13, wherein the composition is provided to the user forintravenous or intramuscular administration.
 25. The method of claim 13,wherein the composition comprises from about 4 g to about 20 g reducedglutathione per 100 mL of the deoxygenated water solvent.
 26. The methodof claim 13, wherein the composition is provided to the user forshort-term treatment of cellular oxidative stress.
 27. The method ofclaim 13, wherein the composition increases blood-serum levels ofreduced glutathione in the user by at least 25%.
 28. The method of claim13, wherein the composition is provided to the user for long-termtreatment of cellular oxidative stress.